A Study to Assess Real-world Patient Characteristics and Clinical Course for Symptomatic Patients With PKP2-ACM

Last updated: May 13, 2025
Sponsor: Lexeo Therapeutics
Overall Status: Active - Recruiting

Phase

N/A

Condition

Circulation Disorders

Treatment

N/A

Clinical Study ID

NCT06976606
LX2020-03
  • Ages 18-65
  • All Genders

Study Summary

An observational study to assess real-world patient characteristics and clinical course of disease in participants with PKP2-ACM.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults with a clinical diagnosis of ACM as defined by the 2010 revised Task ForceCriteria (TFC)

  • Documentation of a pathogenic or likely pathogenic truncating variant in PKP2

  • Frequent premature ventricular contractions (PVCs)

  • Patients must have an ICD placed prior to enrollment

  • Left ventricular ejection fraction (LVEF) ≥ 50% for Part A participants. Leftventricular ejection fraction (LVEF) ≥40% for Part B participants.

Exclusion

Exclusion Criteria:

  • Evidence of variant(s) in addition to PKP2 that meet standard criteria to beconsidered pathogenic or likely pathogenic for an arrhythmogenic cardiomyopathy.

  • A history of other cardiac abnormalities as specified in the protocol.

  • New York Heart Association symptoms of heart failure of Class IV at the time ofconsent.

  • A history of prior gene transfer therapy.

Study Design

Total Participants: 40
Study Start date:
January 23, 2024
Estimated Completion Date:
September 30, 2027

Study Description

SNAPSHOT-PKP2 is an observational, multicenter study that consists of 2 parts, a retrospective EMR review (up to 2 years) and a prospective observational study (1 year), to evaluate the clinical burden of illness of patients with PKP2-ACM, and to prospectively evaluate changes in key cardiac parameters and patient-reported outcome measures (PROMs) associated with PKP2-ACM progression.

Connect with a study center

  • Leland Stanford Junior University

    Redwood City, California 94063-3126
    United States

    Active - Recruiting

  • Johns Hopkins University

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Northshore University Healthsystem Research Institute

    Columbia, Maryland 21044
    United States

    Active - Recruiting

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • University of Rochester

    Rochester, New York 14642
    United States

    Active - Recruiting

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